Quality Assurance Associate

Description Overview

Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being. Originating from the former Omega Pharma, the European branch is today present in 30 countries with a strong local anchorage. 

You know us from brands like Physiomer, NiQuitin, XLS Medical, Zaffranax, Arterin, Dermalex, Biover, Galenco, Davitamon, Ymea, Lactacyd. Perrigo is an organization with a dynamic, transparent and fast-paced atmosphere, characterized by an entrepreneurial and cooperative culture. 

We offer a Hybrid working schedule, a mix of onsite (3 days) and remote (2 days) working each week.

Please note that this is a 12-Month Fixed-Term Contract.

Scope of the Role

Your Responsibilities: 

• Ensure adherence to critical procedures and compliance to requirements for record retention. 
• Set up and maintain Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors).
• Help with due diligence and integration of new product developments / new product introductions for assigned categories.
• Support technical transfers, qualification and validation work.
• Investigate quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with third-party contract manufacturers.
• Evaluate and follow-up Change Controls together with the Regulatory Affairs team.
• Review Product Quality Reviews.
• Agree stability programs and review stability results.
• Be part of third-party qualification and regular third-party auditing.
• Assist in performing internal QA audits.
• Support in the maintenance of the Quality Management System by creating and updating Standard Operating Procedures, Best Practices and Working Instructions.
• Provide support in establishing and maintaining the ISO 9001 and ISO 13485 Quality Management System.
• Provide input to risk management plan and risk management file in line with ICH Q9 and ISO 14971.
• Provide input for analysis of data and/or management review.
• Provide QA training to the entire group regarding QA systems and processes and evaluate training effectiveness.
• Maintain databases and documents according to good documentation practices and record retention procedure.
• Assist in the GDP administrative batch control procedure. 
• Identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives.
• Keep a going awareness of new and developing regulations related to GDPs and GMPs.
• You Will follow up on actions of complaints if requested.
• You will support QA in data and document collection for regulatory purposes.
• You will ensure ongoing inspection readiness in your area of responsibilities.
• Coordinate Change control process and follow-up implementation of changes. 
• Provide evidence to perform review of implementation and effectiveness with regard to corrective and preventive actions.
• Coordinate quarantine shipments and ensure correct release of products that have been shipped under quarantine. 
• Providing support in projects.

Experience Required

Your Qualifications:

• Master degree in pharmaceutical sciences, engineering, biochemistry, chemistry or equivalent through experience.
• At least 3 years relevant experience in Quality Assurance / Quality Control / Production.
• Good knowledge of  the relevant European regulations for pharmaceutical products.
• Knowledge of FDA regulations for pharmaceutical products is an asset.
• Self-starter, capable of working autonomously at corporate level.
• Clear communicator, practical and solution orientated.
• Enthusiastic and get the job done mentality.
• Strong project management skills & team worker in a multicultural environment.
• Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem solving skills.
• You are fluent in spoken and written English; other languages are an asset.